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The Effects of Ozone Therapy on Wound Healing

The Effects of Ozone Therapy on Wound Healing After Gingivectomy Operations: a Controlled Clinical Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03655158
Enrollment
36
Registered
2018-08-31
Start date
2017-02-10
Completion date
2017-11-10
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Heal

Brief summary

the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing.. Twenty three systemically healthy individuals participated in this study. Ozone was applied immediately after surgery, at 1st day and 3rd day after gingivectomy surgery. In the photographs of the wounds, the difference in color were evaluated and measurements were performed at the baseline, 3rd, 7th, 14th days after surgery.

Detailed description

Although ozone therapy has often been tried in medical science and has become more popular due to its antimicrobial, biocompatibility and healing properties, the effects of ozone therapy on surgeries that heals with secondary intention were not studied. In the lights of these informations, the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing. Twenty three systemically healthy individuals participated in this study. All periodontal examinations were performed by one experienced examiner and non-surgical periodontal treatment of the patients were performed within two weeks after initial examination by the same clinician.Gingivectomy and gingivoplasty operations were performed by another examiner who was unaware of the study protocol.After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients. Ozone therapy was also performed by an experienced periodontist. As placebo application, left quadrants received regular air from the ozone generator.Postoperative pain was assessed at 3rd, 7th, 14th days after surgery with a visual analog scale At baseline and 3rd, 7th, 14th days after surgery, surgical area was disclosed by a plaque disclosing solution to visualize the epithelization degree of the surgical areas. Solution provided a clear vision to distinguish normal gingiva from the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization. In order to evaluate epithelization degree of the wounds, standardized photographs were taken from each patient.In the photographs of the wounds, the difference in color were evaluated and darkly stained areas were considered as lack of enough epithelization. These measurements were performed at the baseline, 3rd, 7th, 14th days after surgery. The determinations were done by a calibrated examiner who was blind to test and control sites

Interventions

DEVICEozone device ( Ozonytron XL )

The adjustment of the ozone generator was %75 power for 30 seconds (75 ug/ml) based on manufacturer's instructions

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

placebo applications were performed to mask participant investigator who applied ozone, did not evaluate the healing Investigator who evaluate the healing, did not know the control and test sides.

Intervention model description

Split- mouth placebo controlled design (right quadrants of the surgical areas were assigned to receive ozone therapy in all patients. As placebo application, left quadrants received regular air from the ozone generator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 to 35 years of age * systemically healthy * non-smokers * no medications taken for 6 months * no pregnancy and lactation * no contraindications for periodontal surgery * no gingivectomy or mucogingival surgical history in the lower incisor region.

Exclusion criteria

* \<18 and \> 35 years of age * systemical disease * smoking and alcohol consumption * medications taken for 6 months * pregnancy and lactation * contraindications for periodontal surgery * gingivectomy or mucogingival surgical history in the lower incisor region.

Design outcomes

Primary

MeasureTime frameDescription
wound healing changeAt baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.surgical area was disclosed by a plaque disclosing solution to visualize the epithelization degree of the surgical areas. Solution provided a clear vision to distinguish normal gingiva from the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization. In order to evaluate epithelization degree of the wounds, standardized photographs were taken from each patient

Secondary

MeasureTime frameDescription
Pain changePostoperative pain was assessed at 3rd, 7th, 14th days after surgeryVisual analog scale was used for the pain assesment. On the scale, the left end of the graphic represented the absence of pain (score 0) and the right end represented the most severe pain (score 10).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026